MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Model Number	9-PDA-006
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
It was reported that on (b)(6) 2021, a 10 mm by 8 mm amplatzer duct occluder (ado) was selected for implant in the patient's patent ductus arteriosus (pda) using a 6 fr 180/80 amplatzer torqvue delivery system.During deployment, the ado device did not deploy on the pulmonary artery (pa) side of the pda.The ado device was retracted back into the delivery system once and attempted for delivery again, but the aorta side of the ado went into the pda and became deformed.The device was removed from the patient, and the ado deformation was confirmed outside of the patient.A 6 mm by 4 mm amplatzer duct occluder ii was successfully implanted as a replacement device to resolve this event.The physician believed that the pda closure with the first ado device may have been difficult with the age-related vessel hardness and calcification, as well as the shape and length of the patient's pda.No additional information was provided.
Event or Problem Description
Additional information received that the patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
The reported event of "the aorta side of the ado went into the pda and became deformed" could not be confirmed.One photo was received from the field, which appeared to show device deformation.However, the investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12521985
• Report Number: 2135147-2021-00377
• Device Sequence Number: 4068223
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: 00811806011134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 9-PDA-006
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 7662619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR